立普妥研.pptVIP

研究名称 TNT PROVE-IT IDEAL 纳入人群 稳定型冠心病 入院10日内ACS患者 稳定型冠心病 病例数 10001 4162 8888 药物对比 立普妥10mg VS 立普妥80mg 普伐他汀40mg VS 阿托伐他汀80mg 舒降之20mg VS 立普妥80mg LDL-C基线 130mg/dl 100mg/dl VS 70mg/dl 122mg/dl 治疗后LDL-C基线 101mg/dl VS 77mg/dl 95mg.dl VS 62mg/dl 结果 全因死亡无差异，冠心病死亡下降20%，其他主要心血管事件获益，大剂量组肝酶升高 主要终点下降16%，总死亡下降28%（p=0.07)无统计差异，脑梗无差异 总死亡率无差异，主要冠脉事件下降11% * 各种人群的临床终点研究，无论是一级预防、二级预防、ACS研究，还是卒中研究，均一致性的显示：阿托伐他汀能显著降低各种人群的心脑血管事件。这些研究不但患者群广泛（高血压、糖尿病、冠心病、ACS和卒中），同时剂量范围广泛（从低剂量10mg/d到高剂量80mg/d），设计类型广泛（既有安慰剂对照也有阳性药物对照）。 * 当时批准的普伐他汀的最大日剂量为40mg，阿托伐他汀为80mg。 Treating to New Targets (TNT) Study Slide * Treating to New Targets (TNT) Study Slide * The TNT hypothesis was tested in a double-blind, parallel-group design. A total of 18,469 patients were screened; lipid-lowering therapy was withdrawn, and all patients entered a wash-out phase. 15,464 patients with established CHD and an LDL-C level of 130 to 250 mg/dL (3.4 to 6.5 mmol/L) and with triglycerides ?600 mg/dL (?6.8 mmol/L) were then eligible to enter the 8-week, open-label, run-in period with atorvastatin 10 mg/day. In order that the 2 groups of patients would meet the LDL-C targets during the double-blind phase—and because it would have been unethical to under-treat patients whose LDL-C remained 130 mg/day (3.4 mmol/L)—only those patients with a mean LDL-C 130 mg/dL (3.4 mmol/L) on 10 mg of open-label atorvastatin were entered into the randomized phase of the study. 10,001 patients were randomized to double-blind therapy with either atorvastatin 10 mg/day or 80 mg/day; 5006 patients remained on atorvastatin 10 mg daily and 4995 patients received 80 mg daily. Using the time of randomization as the baseline for the study, patients were then followed for a median of 4.9 years. Reference 1. LaRosa JC, et al. N Engl J Med. 2005;352. Treating to New Targets (TNT) Study Slide * During the open-label period, LDL-C was reduced by 35% in the overall patient population from 152 mg/dL (3.9 mmol/L) to 98 mg/dL (2.5 mmol/L). Following randomization, mean